Macitentan

Drug Profile

Macitentan

Alternative Names: ACT-064992; Actelion-1; Opsumit; Zependo

Latest Information Update: 27 Jan 2017

Price : $50

At a glance

  • Originator Actelion Pharmaceuticals
  • Developer Actelion Pharmaceuticals; Nippon Shinyaku
  • Class Antifibrotics; Antihypertensives; Antineoplastics; Bromobenzenes; Cardiovascular therapies; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides
  • Mechanism of Action Endothelin A receptor antagonists; Endothelin B receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pulmonary hypertension; Idiopathic pulmonary fibrosis; Pulmonary arterial hypertension
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pulmonary arterial hypertension
  • Phase III Eisenmenger complex
  • Clinical Phase Unknown Portal hypertension
  • Discontinued Glioblastoma; Idiopathic pulmonary fibrosis; Skin ulcer

Most Recent Events

  • 23 Jan 2017 Efficacy and adverse events data from the MAESTRO phase III trial in Eisenmenger complex released by Actelion Pharmaceuticals
  • 01 Dec 2016 Actelion completes the phase III MAESTRO trial in Eisenmenger complex in USA, Austria, Belgium, Bulgaria, Chile, China, the Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, the Netherlands, the Philippines, Poland, Portugal, Romania, Russia, Serbia, Spain, Taiwan, Turkey, United Kingdom and Vietnam (NCT01743001)
  • 07 Nov 2016 Efficacy and safety data from phase III MERIT trial in Pulmonary arterial hypertension released by Actelion
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